(a) The actions of all primary inspection agencies shall be monitored at a frequency adequate to assure that they are performing consistently and fulfilling their responsibilities under these regulations. Every aspect of the primary inspection agencies' performance shall be monitored.

(b) Frequency of monitoring. The performance of each primary inspection agency shall be monitored during its period of provisional acceptance by a complete review of its records and, in the case of IPAs, by a complete inspection of the operations of at least one manufacturing plant which it has approved or in which it is operating. After the initial inspection, the performance of each primary inspection agency shall be monitored four times per year, except that the number of monitoring visits may be decreased to a minimum of one per year if the performance of the primary inspection agency is deemed by the Secretary or the Secretary's agent to be superior, and it may be increased as necessary if performance is suspect. There shall be a minimum of one review per year of the records of each primary inspection agency, and there shall be more reviews as needed.